FDA Inspection 1056839 — Hyundai Bioscience Co., Ltd.
The FDA completed an inspection of Hyundai Bioscience Co., Ltd. on June 22, 2018 in Gimcheon. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 22, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gimcheon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |